Disodium 2-oxoglutarate

Particle size distribution (Granulometry)

Administrative data

Endpoint:

particle size distribution (granulometry)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24 March 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 110 (Particle Size Distribution / Fibre Length and Diameter Distributions) - Method B: Fibre Length and Diameter Distributions

Version / remarks:

1981

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

ISO 13320 (Particle size analysis - Laser diffraction methods)

Version / remarks:

2009

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 830.7520 (Particle Size, Fiber Length, and Diameter Distribution)

Version / remarks:

1996

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

Laser scattering/diffraction

Type of distribution:

volumetric distribution

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 2-oxoglutarate

EC Number:

206-167-8

EC Name:

Disodium 2-oxoglutarate

Cas Number:

305-72-6

Molecular formula:

C5H6O5.2Na

IUPAC Name:

disodium 2-oxopentanedioate

impurity 1

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

Oxidane

Test material form:

solid: crystalline

Remarks:

Crystalline powder

Details on test material:

Batch No: 14152300
Storage: 15 – 25 °C

Specific details on test material used for the study:

Since the test item contains no lager particles, sieving < 2000 µm was not necessary and the test item was used as delivered.

Results and discussion

Particle size

Particle size 1

Key result

Percentile:

D10

Mean:

1.3 µm

St. dev.:

0

Remarks on result:

other: mean of two test series (1.3 µm; 1.3 µm)

Particle size 2

Key result

Percentile:

D50

Mean:

105.7 µm

St. dev.:

0.93

Remarks on result:

other: mean of two test series (106.6 µm; 104.8 µm)

Particle size 3

Key result

Percentile:

D90

Mean:

581.3 µm

St. dev.:

4.87

Remarks on result:

other: mean of two test series (576.4 µm; 581.3 µm)

Any other information on results incl. tables

Light microscopy

At all three magnifications (5x, 20x, 50x) only agglomerates can be observed. 

Particle size distribution

The test item shows a bimodal particle size distribution with two peaks at approx. 2.5 µm and 400 µm.

Test series 1:

Percentile	Particle size (µm)	Standard deviation
D10	1.3	0.02
D50	106.6	7.13
D90	576.4	31.9

Test series 2:

Percentile	Particle size (µm)	Standard deviation
D10	1.3	0.02
D50	104.8	7.21
D90	581.3	41.4

Applicant's summary and conclusion

Conclusions:

The test item a-Ketoglutarate disodium salt (CAS no. 305-72-6) has a median particle size D50 = 105.7 µm, which was determined by laser diffraction measurement according to OECD Test Guideline 110 (1981), ISO 13320 (2009) and EPA OCSPP Guideline OPPTS 830.7520 (1996).

Executive summary:

The test item a-Ketoglutarate disodium salt (CAS no. 305-72-6) has a median particle size D50 = 105.7 µm, which was determined by laser diffraction measurement according to OECD Test Guideline 110 (1981), ISO 13320 (2009) and EPA OCSPP Guideline OPPTS 830.7520 (1996).